US and Europe Radiopharmaceutical Market Overview
The US & Europe Radiopharmaceutical Market is expected to grow at a significant CAGR during the forecast period (2024-2031).
Radioligand therapy (RLT) is a therapeutic option for the treatment of cancer. The radiopharmaceutical is injected into the peripheral vein. Ligands are labelled with radioisotopes, mostly beta-emitters, such as lutetium-177. The high rate of long-lasting tumour remission and stabilization is achieved using radioligand therapy (RLT).
RLT is a systemic therapy used for metastasized disease treatment. In radioligand therapies, radiopharmaceuticals bind to a tumour target.
NET radioligand therapy is also called peptide-receptor radionuclide therapy (PRRT). NET peptides targeting the somatostatin-receptor (SSTR) are used for the treatment of neuroendocrine tumours.
Radioligand specifically binds prostate-specific membrane antigen (PSMA) for prostate cancer treatment. Prostate-specific membrane antigens (PSMA) are overexpressed in prostate cancer
The global radioligand therapy (RLT) market growth is driven by an increase in the footprint of pharmaceutical manufacturers in potential markets in the
Asia Pacific, Latin America, and Middle East & Africa.
Research & development of radioligand therapy candidates to treat a broad range of cancer types is expected to boost the global radioligand therapy
Treatment market during the forecast period.
Endocyte's Lu-PSMA-617 is a radioligand therapy candidate which is currently under phase III clinical trials for the treatment of prostate cancer.
The rising prevalence of cancer globally is expected to fuel the market growth during the forecast period. As per the American Cancer Society, in the United
States, around 174,650 new cases for prostate cancer were diagnosed in 2019.
The strategic acquisition by major players operating in radioligand therapy is encouraging manufacturers in expanding the cancer product pipeline.
Hence, approval and commercialization of pipeline products in the near future is expected to propel the market during the forecast period.
In December 2018, Novartis acquired Endocyte to purchase Endocyte's Lu-PSMA-617 clinical product.
In December 2019, IRE Elit and Isologic received approvals of the Gallium-68 generator, Galli Eo®, as a drug in Canada. Galli Eo® is approved in Canada for
in vitro radiolabeling of radiopharmaceuticals ligands for diagnostic procedures using positron emission tomography (PET) and represents a major
advance for specialists in nuclear medicine and functional molecular medical imaging.
In March 2020, Debiopharm, a Swiss-based biopharma company, has agreed with 3B Pharmaceuticals (3BP), a German biotechnology
firm, to further develop their Debio 0228 radioligand program, which targets the CAIX (Carbonic Anhydrase 9) enzyme to fight the progression of cancer.
The agreement extends Debiopharm’s radio-oncology portfolio, which currently includes another clinical-stage radiotherapeutic and the radiotherapy enhancing antagonist of IAPs (Inhibitors of Apoptosis proteins) Debio 1143.
Governments in Europe have favourable reimbursement policies. Furthermore, an increase in research laboratories, a rise in the prevalence of cancer, and an increase in funding provided by governments are anticipated to propel the market in the region during the forecast period. Every year, more than 8,500 new prostate cancers are detected in Belgium. Prostate cancer is the second most common cancer among men, causing around 90,000 deaths per year in Europe.
One of the most promising approaches to treating it involves the use of a therapeutic radioisotope, Lu-177. This radioisotope is used in hospitals to treat neuroendocrine cancers which commonly affect the digestive system, mainly the stomach, pancreas and bowels.
The need for Lu-177 to treat prostate cancer through clinical trials is growing. IRE and SCK CEN are expecting the global demand to triple in the coming years. On 3 rd February 2020 IRE (Institut National des Radioéléments) and SCK CEN joined forces to benefit medicine. Both organizations specialized in the research, development and production of medical radioisotopes, signed a public-public partnership whose initial aim is to produce lutetium-177 (Lu-177). This medical radioisotope gives a ray of hope to treat prostate cancer, which causes around 90,000 deaths per year in Europe.
Also, on January 21st 2020, SHINE Medical Technologies LLC, the Institute of Organic Chemistry and Biochemistry (IOCB Prague) and GE Healthcare announced the production of patient dose quantities of the therapeutic isotope lutetium-177 (Lu-177). The lot passed GE Healthcare’s quality control testing, including internationally recognized radionuclide purity (RNP) standards. The delivery of Lu-177 in this quantity and purity demonstrates the suitability of the IOCB technology for Lu-177 production.
On March 2 and 2020, ITM Isotopen Technologien München AG (ITM), a biotechnology and radiopharmaceutical group of companies has expanded an agreement for the supply of highly pure no-carrier-added (n.c.a.) Lutetium-177 (177Lu), which was originally concluded in 2018 between ITM AG and Endocyte, Inc., a Novartis company. Under the agreement, ITM will provide Endocyte with the supply of n.c.a 177Lu for its investigational 177Lu-PSMA-617 radioligand therapy for patients with metastatic castration-resistant prostate cancer.
US and Europe Radiopharmaceutical Market Dynamics
The rising prevalence of cancer globally is expected to fuel the market growth during the forecast period.
Prostate cancer is the second leading cause of cancer death in American men, behind only lung cancer. About 1 man in 41 will die of prostate cancer.
Prostate cancer can be a serious disease, but most men diagnosed with prostate cancer do not die from it. More than 3.1 million men in the United States who have been diagnosed with prostate cancer at some point are still alive today.
As per the American Cancer Society, in the United States, around 174,650 new cases of prostate cancer were diagnosed in 2019.
As per the World Health Organization (WHO), cancer is the second leading cause of death worldwide and is responsible for around 9.6 million deaths in 2018. ➢ Europe has the second-highest cancer incidence, followed by North America.
In terms of the increase in cancer incidence, Europe is anticipated to have the slowest growth in the forecast period.
In terms of growth of cancer incidence, Middle and North Africa and South America are considered to be the top two regions with a CAGR of 3.1% and 2.9%, from 2012 to 2030, respectively.
Hence, the rising prevalence of cancer is driving the growth of the radioligand market.
US and Europe Radiopharmaceutical Market Segmentation
By Radioisotopes
The Lutathera market is expected to reach a value of US$ XX Mn by 2027 growing at a CAGR of XX%
The Lutathera market is expected to create an incremental opportunity of US$ XX Mn during the forecast period.
In January 2018, LUTATHERA (lutetium Lu 177 dotatate) was approved by the FDA for the treatment of somatostatin receptor (SSTR) positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumours in adults.
The approval of Lutathera in Europe was granted in September 2017 by the EMA. In January 2019, it has also received approval from Canada Health. The holder of the marketing authorizations is Advanced Accelerators Applications S.A. (AAA, a Novartis company).
This therapy is used for inoperable, advanced metastatic disease of the digestive tract, including pancreatic neuroendocrine tumours, with positive somatostatin receptor imaging. Treatment with Lutathera is appropriate for adults who have not responded to other treatments. Diagnostic imaging with a Galium-68 PET/CT scan is used to locate tumours that are most likely to respond to the therapy.
Lutathera contains a lutetium Lu-177 labelled somatostatin analogue peptide. NETs have receptors for somatostatin. The drug carries a radioactive component for treatment. The drug binds to the somatostatin receptor-expressing cells and destroys the tumour cells.
The drug is administered intravenously at our new Infusion Center at UC San Diego Medical Center in Hillcrest. Patients typically receive one injection of Lutathera, followed by an injection of long-acting octreotide (a hormone therapy), every eight weeks for a total of four injections
By Region
The United States radioligand therapy (RLT) Market is valued at US$ XX Million in 2019 and is estimated to grow at a CAGR of XX% over the forecast period to reach US$ XX Million by 2027.
The United States is projected to lead the market during the forecast period, with a high rate of adoption of radioligand therapy products after FDA approval. According to Novartis, Lutathera has been prescribed to over 1,100 patients in the U.S.
The United States is estimated to account for the largest share of the market, owing to the rising prevalence of cancer, advancements in technology, and the introduction of new radiopharmaceuticals for diagnosis.
An increase in awareness about radioligand therapy and a rise in the patient base suffering from cancer in the U.S. is expected to drive the market in the region. Manufacturers are focused to enter into partnerships with laboratories for research & development of radioligand therapy candidates which is anticipated to propel the market in the U.S.
In 2016, the AMIPA (American Medical Isotope Production Act) and the DOE/NNSA (Department of Energy) established a Uranium Lease and Take-Back (ULTB) program in the United States.
The premise of the American Medical Isotopes Production Act is: “To promote the production of molybdenum-99 in the United States for medical isotope production, and to condition and phase out the export of highly enriched uranium for the production of medical isotopes.” Under the Act, the Secretaries for Energy and Health and Human Services have to assess whether there are adequate supplies of Mo-99 coming into the U.S. from sources other than highly enriched uranium (HEU) sources.
